A Treatment Protocol For Patients Continuing From A Prior SU011248 Protocol.

NCT00443534 | Completed Results

• 1 other identifier: A6181078
• Study Type: interventional
• Target: 123
• Locations: 7 countries
• Sites: 62

Brief Summary

This protocol allows subjects who have participated in a previous SU011248 protocol the ability to continue to receive SU011248 after their study has ended.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  Baseline up to Day 28 after last dose of study treatment

Other Outcomes (3)

• Overall Survival (OS)

  Baseline, every 2 months until death or up to 2 years after the last dose of study treatment

• Progression-Free Survival (PFS)

  Baseline, every 2 months until objective tumor progression or death or up to 2 years after the last dose of study medication

• Time to Tumor Progression (TTP)

  Baseline, every 2 months until objective tumor progression or up to 2 years after the last dose of study medication

Study Arms (1)

1

EXPERIMENTAL

Drug: SU011248

Interventions

SU011248 DRUG

Administered orally in doses ranging from 25 to 50 mg once daily; dosing schedule and dosage depends on the patients dosing from the prior protocol

Also known as: Sutent/Sunitinib

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participation in a previous SU011248 protocol and are judged by the investigator to have the potential to derive clinical benefit by remaining on SU011248 after the prior protocol ends.

You may not qualify if:

• Severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (62)

Pfizer Investigational Site

Aurora, Colorado, 80045, United States

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Littleton, Colorado, 80120, United States

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Orlando, Florida, 32806, United States

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Atlanta, Georgia, 30322, United States

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Harvey, Illinois, 60426-4265, United States

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Harvey, Illinois, 60426, United States

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Maywood, Illinois, 60153, United States

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Tinley Park, Illinois, 60477, United States

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Zion, Illinois, 60099, United States

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Munster, Indiana, 46321, United States

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Baltimore, Maryland, 21201, United States

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Grand Rapids, Michigan, 49503, United States

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City of Saint Peters, Missouri, 63376, United States

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Creve Coeur, Missouri, 63141, United States

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St Louis, Missouri, 63110, United States

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Las Vegas, Nevada, 89135, United States

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Hackensack, New Jersey, 07601, United States

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Chapel Hill, North Carolina, 27599-7600, United States

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Clinton, North Carolina, 28328, United States

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Goldsboro, North Carolina, 27534, United States

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Hickory, North Carolina, 28602, United States

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Wilson, North Carolina, 27893, United States

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Oklahoma City, Oklahoma, 73120, United States

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Tulsa, Oklahoma, 74104, United States

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Tulsa, Oklahoma, 74133, United States

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Tulsa, Oklahoma, 74136, United States

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Hershey, Pennsylvania, 17033, United States

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Greenville, South Carolina, 29615, United States

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Greer, South Carolina, 29650, United States

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Spartanburg, South Carolina, 29307, United States

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Bedford, Texas, 76022, United States

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Dallas, Texas, 75246, United States

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Fort Worth, Texas, 76177, United States

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Houston, Texas, 77030, United States

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San Antonio, Texas, 78207, United States

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San Antonio, Texas, 78217, United States

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San Antonio, Texas, 78229, United States

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San Antonio, Texas, 78258, United States

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Edmonton, Alberta, T6G 1Z2, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Montreal, Quebec, H2L 4M1, Canada

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Montreal, Quebec, H3G 1A4, Canada

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Montreal, Quebec, H3G 1L5, Canada

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Lyon, 69373, France

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Marseille, 13915, France

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Villejuif, 94805, France

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Berlin, 10117, Germany

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Großhansdorf, 22927, Germany

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Hamburg, 20246, Germany

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Wiesbaden, 65199, Germany

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Bologna, 40138, Italy

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Cremona, 26100, Italy

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Genova, 16132, Italy

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Milan, 20133, Italy

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Orbassano (TO), 10043, Italy

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Rozzano (MI), 20089, Italy

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Elche, Alicante, 03203, Spain

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Barcelona, Barcelona, 08003, Spain

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Córdoba, Cordoba, 14004, Spain

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Sutton, Surrey, SM2 5PT, United Kingdom

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London, SW3 6JJ, United Kingdom

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Pfizer Investigational Site

Manchester, M20 4BX, United Kingdom

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Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Neoplasms

Interventions

Sunitinib

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

The reason for not completed 'Study Terminated by Sponsor' in participant flow table indicates the termination of study at few sites as captured in case report forms at those sites and does not reflect overall status of study.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2007
• First Posted: March 6, 2007
• Study Start: May 1, 2006
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 24, 2013
• Results First Posted: May 24, 2013

Record last verified: 2013-04

Locations

GB (3); DE (4); IT (6); ES (3); CA (5); FR (3); US (38)